BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1952898 · Received January 7, 2011

    Report

    Report Number
    3005099803-2010-05462
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE TAIL WAS BENT OUT OF THE CLEVIS. FUNCTIONALLY, THE DEVICE JAWS WOULD OPEN AND CLOSE NORMALLY CONSIDERING THE BENT NEEDLE TAIL. AS A RESULT, MEASUREMENTS WERE TAKEN OF THE PULL WIRE CURVES AND WERE FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT A WIRE WAS PROTRUDING AT THE LOCATION OF THE BIOPSY JAW HINGE. BASED ON THE GATHERED INFORMATION AND THE ANALYSIS OF THE DEVICE, THE FAILURE FOUND WITH THE RETURNED DEVICE COULD BE CAUSED DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH CAUSED THE PRODUCT'S PERFORMANCE TO BE LIMITED. ADDITIONALLY THE DFU INDICATES THAT THE PACKAGING AND THE DEVICE SHOULD BE INSPECTED PRIOR TO USE. DO NOT USE THE DEVICE IF THE PRODUCT OR PACKAGING IS DAMAGED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AS A BIOPSY SPECIMEN WAS ABOUT TO BE OBTAINED, A WIRE COULD BE SEEN PROTRUDING AT THE LOCATION OF THE BIOPSY JAW HINGE. THEY DID NOT ATTEMPT TO OBTAIN A BIOPSY SAMPLE. THE FORCEPS WERE REMOVED FROM THE PATIENT. ADDITIONALLY, IT WAS NOTED THAT THERE WAS NO SCOPE DAMAGE, AND THE JAWS WERE ABLE TO BE OPENED AND CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AS A BIOPSY SPECIMEN WAS ABOUT TO BE OBTAINED, A WIRE COULD BE SEEN PROTRUDING AT THE LOCATION OF THE BIOPSY JAW HINGE. THEY DID NOT ATTEMPT TO OBTAIN A BIOPSY SAMPLE. THE FORCEPS WERE REMOVED FROM THE PATIENT. ADDITIONALLY, IT WAS NOTED THAT THERE WAS NO SCOPE DAMAGE, AND THE JAWS WERE ABLE TO BE OPENED AND CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513331 13664652

    Patients

    Seq Age Sex Outcome Treatment
    1